MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-01 for MEIJER MTH GD RST ASRD EX COMF 2CT MTH GD RST ASRD EX COMF 2CT CRTN manufactured by Ranir Llc.
[115776251]
Consumer asked what material is the night guard made of and she believed she was having an allergic reaction to it. On (b)(6) 2018 consumer used the guard three nights and she didn't use the night before she called. She did not have hives in my mouth this morning and the swelling of my lips went down considerably. At first consumer thought she had chapped lips but each day the symptoms grew worse. Later she thought this could be a reaction because the night guard was the only new addition in her life. She has never bought an over the counter night guard before. Benadryl helped with the symptoms, she only needed to take one dose. The product was very easy to use and the instructions were very clear. The fit was great.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825660-2018-00376 |
| MDR Report Key | 7738806 |
| Date Received | 2018-08-01 |
| Date of Report | 2018-08-01 |
| Date of Event | 2018-07-05 |
| Date Facility Aware | 2018-07-05 |
| Date Mfgr Received | 2018-07-05 |
| Date Added to Maude | 2018-08-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | REBEKAH STENSKE |
| Manufacturer Street | 4701 EAST PARIS AVE. SE |
| Manufacturer City | GRAND RAPIDS MI 495125353 |
| Manufacturer Country | US |
| Manufacturer Postal | 495125353 |
| Manufacturer Phone | 6166988880 |
| Manufacturer G1 | RANIR LLC |
| Manufacturer Street | 4701 EAST PARIS AVE. SE |
| Manufacturer City | GRAND RAPIDS MI 495125353 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 495125353 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEIJER MTH GD RST ASRD EX COMF 2CT |
| Generic Name | MOUTHGUARD, OVER-THE-COUNTER |
| Product Code | OBR |
| Date Received | 2018-08-01 |
| Model Number | MTH GD RST ASRD EX COMF 2CT CRTN |
| Lot Number | 229208 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RANIR LLC |
| Manufacturer Address | 4701 EAST PARIS AVE. SE GRAND RAPIDS MI 495125353 US 495125353 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-01 |